The FDA warned that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. The injections are given to treat neck and back pain, and radiating pain in the arms and legs. The FDA required the addition of a warning to the drug labels of injectable corticosteroids to describe these risks. Patients should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments.
Injectable corticosteroids are commonly used to reduce swelling or inflammation. Injecting corticosteroids into the epidural space of the spine has been a widespread practice for many decades. However, the effectiveness and safety of the drugs for this use have not been established, and the FDA has not approved corticosteroids for such use. The FDA started investigating this safety issue when it became aware of medical professionals’ concerns about epidural corticosteroid injections and the risk of serious neurologic adverse events. This concern prompted the FDA to review cases in the FDA Adverse Event Reporting System (FAERS) database and in the medical literature.
Injectable corticosteroids include methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone. Patients should be counseled to seek emergency medical attention immediately if they experience symptoms after receiving an epidural corticosteroid injection, such as loss of vision or vision changes; tingling in the arms or legs; sudden weakness or numbness in the face, arm or leg on one or both sides of the body; severe headache; or seizures.
Serious adverse events included death, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, stroke, seizures, nerve injury, and brain edema. Adverse events have occurred within minutes to 48 hours after the injections. Many patients did not recover from these reported adverse events. This safety issue is unrelated to the contamination of compounded corticosteroid injection products reported in 2012.
See the FDA Drug Safety Announcement
See also Medical Law Perspectives, January 2014 Report: Prescription Painkillers: Risks for Patients, Pharmacists, and Physicians
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication
See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe